This invention relates to the field of ostomy drainage devices.
Patients frequently have bowel diseases, most often cancer, which requires removing the lower portion of the bowel, therefore interrupting the normal flow on the intestinal contents and normal evacuations via the rectum. These patients have either their large bowel, the colon, introduced through anterior abdominal wall as a colonoscopy; or, the small intestine, the ileum, brought through the anterior abdominal wall as an ileostomy. That is, a large bowel or small intestine resection may necessitate a surgically created ostomy through a portion of the abdominal wall for the evacuation of bodily waste. In such cases the proximal portion of the severed bowel is drawn through the abdominal wall and secured to the exterior surface of the abdomen. A waste receptacle is generally required to be continuously held or mounted in place over the stoma and removed for emptying. Such receptacles are generally not readily disposable in the standard sewer or septic system and are not reusable.
Conventionally such individuals wear a bag attached to the anterior abdominal surface which continually collects stool and bowel contents throughout a twenty four hour period. Patients empty the bag periodically and replace it with a new collection apparatus. Therefore, such individuals are always walking around with a collection bag with various amounts of bowel contents. Even though these devices are worn under a patient's clothes, the patient remains aware of the presence of the device and the collection bag. Such collection bags when worn continuously, will, as one may envision, greatly restrict the normal activities of the wearer such as swimming, bathing, may be prone to leakage and to the emitting of unwanted odours.
In the prior art applicant is aware of U.S. Pat. No. 4,344,434 which issued to Robertson on Aug. 17, 1982 for an ileostomy Appliance and Method for Implementing the Same. Robertson discloses the use of a tube which is inserted into an ostomy so as to abut a plate at one end of the tube against the patient's skin. An inflatable balloon at the other end of the tube is employed to anchor the tube in the ostomy. A flexible unidirectional valve, taught to be a miter valve, is mounted within the tube. The unidirectional valve has flexible sealing members the ends of which are located remotely from the plate. The ends of the flexible sealing members terminate in flexible lips which are normally biased to maintain the edges thereof in engagement with each other to form a fluid-tight seal. A catheter is provided which when inserted through the plate end of the tube engages the flexible sealing members of the unidirectional valve so as to separate the edges of the flexible lips to form an opening through which the catheter may be inserted. The edges of the flexible lips form a fluid-tight sliding sealing engagement with the exterior outer surface of the catheter.
The catheter of Robertson has a conically shaped stop which prevents further sliding of the catheter into the tube once the catheter has been pushed through the unidirectional valve. The opposite end of the catheter may be angled relative to the end inserted into the tube and may be adapted to have a drain tube removably attached thereto for fluid communication into a fluid collecting member. What is not provided for, and which is an object of the present invention to provide, is a further means of sealing unwanted discharge from the ostomy in the event that the unidirectional valve leaks, for example due to diminished resilient biasing of the sealing members caused by hysteresis of the valve material, or, when the valve is in the opened position, due to a faulty seal around the circumference of the catheter. Thus a backup sealing device is provided for continent sealing of the ostomy drainage device when the patient does not desire to wear an ostomy collection bag and for sealing around the ostomy during discharge of waste into an ostomy collection bag.
It is, therefore, another object of the present invention to mount securely within a bowel ostomy a valved drainage conduit that is securely sealable by a threaded cap or other means of closure against leakage of either liquid or vapor.